FDA Authorizes Marketing of First At-Home Test for Chlamydia, Gonorrhea, Trichomoniasis

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The US FDA granted Visby Medical authorization to market their at-home, over-the-counter diagnostic test that detects chlamydia, gonorrhea, and trichomoniasis, according to a press release.¹

The Women’s Sexual Health Test (Visby Medical) is intended for women regardless of symptom status and delivers results in approximately 30 minutes using a vaginal swab, the FDA said in the March 28, 2025, press release.¹

The main risk individuals using the test should be aware of is the possibility of false positive and false negative results, according to the release.¹

“Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” Courtney Lias, PhD, director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.¹ “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.”

The CDC reported over 2.2 million cases of chlamydia and gonorrhea in the US in 2023.² Trichomoniasis, estimated to affect approximately 2.6 million individuals in the US, is the most common nonviral sexually transmitted infection (STI) globally.³ If left untreated, these infections can lead to complications such as infertility.¹

The Visby Medical Women’s Sexual Health Test consists of a self-collected vaginal swab and a powered testing device, which securely communicates results through the Visby Medical App. In clinical evaluations, the test demonstrated high accuracy, correctly identifying 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples, and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples.¹

Individuals who test positive for any of the 3 infections are advised to seek medical care. Those with symptoms or recent STI exposure should consult a health care professional, even if their test result is negative. The FDA highlighted the risks associated with false positive and false negative results, which could lead to unnecessary treatment or delays in appropriate care.¹

The FDA reviewed the test under its De Novo premarket review pathway, which allows for the evaluation of low- to moderate-risk devices that are the first of their kind. This authorization establishes a new regulatory classification, enabling future at-home STI tests of the same type to seek approval through the FDA’s 510(k) pathway by demonstrating substantial equivalence to the Visby Medical Women’s Sexual Health Test.¹

The announcement follows the authorization of the first at-home syphilis test in August 2024.⁴

References:

1. FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis. News release. FDA. March 28, 2025. Accessed March 31, 2025. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis

2. Jennings S. STI Epidemic in US Shows Signs of Slowing, According to New CDC Report. Patient Care Online. November 13, 2024. https://www.patientcareonline.com/view/sti-epidemic-in-us-shows-signs-of-slowing-according-to-new-cdc-report

3. Centers for Disease Control and Prevention. Trichomoniasis – STI treatment guidelines, 2021. CDC. Updated July 22, 2021. Accessed March 31, 2025. https://www.cdc.gov/std/treatment-guidelines/trichomoniasis.htm

4. Jennings S. First At-Home, OTC Syphilis Test Granted Marketing Authorization by FDA. Patient Care Online. August 19, 2024. https://www.patientcareonline.com/view/first-at-home-otc-syphilis-test-granted-marketing-authorization-by-fda